Clinical trials: sponsored by Stemline Therapeutics, Inc.
Hematological Malignancy
KATALYST-HEME-01: Study of the KAT6 Inhibitor MEN2312 in Heme Malignancies
This study will evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and activity of MEN2312 in participants with hematological malignancies.
- Trial name
- NCT07873827
- Testing
- MEN2312
- Volunteers
- 115 people
- Sponsor
- Stemline Therapeutics, Inc.
Breast Cancer
A Phase 2 Bridging Study of Elacestrant Monotherapy in Advanced or Metastatic Breast Cancer
This is a multicenter, open-label, Phase 2 bridging study to evaluate the efficacy and safety of elacestrant in Japanese post-menopausal women and men with estrogen receptor positive (ER+)/human epidermal growth factor receptor 2…
- Trial name
- NCT07766018
- Testing
- Elacestrant
- Where
- 19 sites in Japan
- Volunteers
- 70 people
- Sponsor
- Stemline Therapeutics, Inc.
Breast Neoplasms, Brain Neoplasms
Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer
This is a multi-site, global, open-label study that includes a phase 1b evaluation of elacestrant in combination with abemaciclib in women and men with brain metastases from estrogen receptor (ER)-positive, human epidermal growth…
- Conditions
- Breast Neoplasms, Brain Neoplasms, Neoplasms by Site, Neoplasms
- Trial name
- ELECTRA (NCT05386108)
- Testing
- Elacestrant, Abemaciclib
- Where
- 86 sites in United States, Belgium and 8 more
- Volunteers
- 73 people
- Sponsor
- Stemline Therapeutics, Inc.
Breast Cancer
A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence
The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative…
- Trial name
- ELEGANT (NCT06492616)
- Testing
- Elacestrant, Anastrozole, Letrozole
- Where
- 567 sites in United States, Argentina and 26 more
- Volunteers
- 4,220 people
- Sponsor
- Stemline Therapeutics, Inc.
Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
A Non-interventional Study of Participants With BPDCN Treated With Chemotherapy
The main goal of this study is to investigate the effectiveness and safety of chemotherapy agents in the treatment of participants with BPDCN and to provide comparator arm data to the prospective ELZONRIS registry study…
- Trial name
- NCT07785180
- Testing
- Chemotherapy
- Where
- 67 sites in Denmark, France and 9 more
- Volunteers
- 140 people
- Sponsor
- Stemline Therapeutics, Inc.
Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
A Registry-study of ELZONRIS in Participants With BPDCN
The main goal of this registry study is to investigate the effectiveness and safety of tagraxofusp in the treatment of adult participants with BPDCN in the real-world clinical practice setting.
- Trial name
- NCT07785154
- Testing
- Tagraxofusp
- Where
- 41 sites in Austria, Germany and 2 more
- Volunteers
- 80 people
- Sponsor
- Stemline Therapeutics, Inc.
Advanced Breast Cancer
A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer
This is a first-in-human study of MEN2312, a lysine acetyltransferase 6 (KAT6) inhibitor, in adult participants with advanced breast cancer.
- Trial name
- NCT06638307
- Testing
- MEN2312, Elacestrant
- Where
- 45 sites in United States, Spain
- Volunteers
- 240 people
- Sponsor
- Stemline Therapeutics, Inc.
Acute Myeloid Leukemia
A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy
This study will be divided into 2 parts (Part 1 and Part 2). Part 1 will evaluate 2 doses of tagraxofusp (9 and 12 micrograms/kilogram/day [μg/kg/day]), used in combination with venetoclax and azacitidine, to determine the dose…
- Trial name
- TRILLIUM (NCT06456463)
- Testing
- Tagraxofusp, Venetoclax, Azacitidine
- Where
- 32 sites in United States, Australia
- Volunteers
- 85 people
- Sponsor
- Stemline Therapeutics, Inc.
Platinum-resistant Ovarian Cancer
A First-in-Human Study of MEN2501 in Participants With Platinum-Resistant Ovarian Cancer
This is a first-in-human, open-label, dose-escalation, dose-optimization trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of MEN2501 monotherapy in adult participants…
- Trial name
- NCT07226427
- Testing
- MEN2501
- Where
- 15 sites in United States, Australia and 1 more
- Volunteers
- 100 people
- Sponsor
- Stemline Therapeutics, Inc.
Breast Cancer, Metastatic Breast Cancer
Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer
This is a multicenter, Phase 1b/2 trial in participants with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced/metastatic breast cancer.
- Trial name
- ELEVATE (NCT05563220)
- Testing
- Elacestrant, Alpelisib, Everolimus
- Where
- 83 sites in United States, Argentina and 11 more
- Volunteers
- 435 people
- Sponsor
- Stemline Therapeutics, Inc.
Metastatic Breast Cancer
ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study
The purpose of this study is to evaluate the efficacy and safety of elacestrant over the course of 6 months in patients with estrogen receptor positive (ER+)/human epidermal growth factor receptor-2 negative (HER2-)…
- Trial name
- ELCIN (NCT05596409)
- Testing
- Elacestrant
- Where
- 22 sites in United States, Brazil and 4 more
- Volunteers
- 61 people
- Sponsor
- Stemline Therapeutics, Inc.
Breast Cancer
Phase 3 Trial of Elacestrant Versus Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
This Phase 3 clinical study compares the efficacy and safety of elacestrant to the standard of care (SoC) options of fulvestrant or an aromatase inhibitor (AI) in women and men with breast cancer whose disease has advanced on at…
- Trial name
- EMERALD (NCT03778931)
- Testing
- Elacestrant, Standard of Care
- Where
- 244 sites in United States, Argentina and 15 more
- Volunteers
- 478 people
- Sponsor
- Stemline Therapeutics, Inc.
Solid Tumors
A Trial of a Novel XPO1 Inhibitor in Participants With Advanced Solid Tumors
Study SL-801-0115 is a dose-escalation study evaluating multiple doses and schedules of orally administered SL-801 in participants with advanced solid tumors.
- Trial name
- NCT02667873
- Testing
- SL-801
- Where
- 6 sites in United States
- Volunteers
- 72 people
- Sponsor
- Stemline Therapeutics, Inc.
Adult Brain Glioblastoma, Glioblastoma Multiforme
Safety and Efficacy Study of SL-701, a Glioma-Associated Antigen Vaccine To Treat Recurrent Glioblastoma Multiforme
The purpose of this study is to determine the safety and efficacy of SL-701 as a treatment for recurrent glioblastoma multiform (GBM).
- Trial name
- NCT02078648
- Testing
- SL-701; poly-ICLC (polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethyl cellulose), Bevacizumab, SL-701 + GM-CSF
- Where
- 16 sites in United States
- Volunteers
- 74 people
- Sponsor
- Stemline Therapeutics, Inc.
Advanced Solid Tumor
Study of the PI3K Inhibitor SL-901 in Patients With Advanced Solid Tumors
Study STML-901-0119 was a dose-escalation study evaluating multiple doses and schedules of orally administered SL-901 in patients with advanced solid tumors.
- Trial name
- NCT05382936
- Testing
- SL-901
- Where
- 2 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- Stemline Therapeutics, Inc.
Myelofibrosis, Chronic Myelomonocytic Leukemia
Tagraxofusp (SL-401) in Participants With Chronic Myelomonocytic Leukemia (CMML) and Myelofibrosis (MF)
This multicenter, multi-arm trial evaluated the safety and efficacy of tagraxofusp, a cell division cycle protein 123 homolog-targeted therapy, in participants with either CMML or MF.
- Trial name
- NCT02268253
- Testing
- Tagraxofusp Injection
- Where
- 24 sites in United States, Canada
- Volunteers
- 82 people
- Sponsor
- Stemline Therapeutics, Inc.
Hepatic Impairment
A PK Study Testing Single Oral Dose of Elacestrant in Subjects With Normal or Severely Impaired Hepatic Function
This is a Phase 1, multi-center, open-label, non-randomized, parallel group study to evaluate the effect of severe hepatic impairment on the PK, safety and tolerability of a single oral dose of Elacestrant.
- Trial name
- NCT06126575
- Testing
- Elacestrant dihydrochloride
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Stemline Therapeutics, Inc.
Acute Myeloid Leukemia
SL-401 as Consolidation Therapy in Patients With Adverse Risk Acute Myeloid Leukemia in First Complete Remission
This is a non-randomized, open-label, multicenter, dose escalation study designed to determine the maximum tolerated dose (MTD) of SL-401 in adult patients with acute myeloid leukemia, and to evaluate the safety profile of SL-401…
- Trial name
- NCT02270463
- Testing
- Tagraxofusp-erzs
- Where
- 7 sites in United States
- Volunteers
- 16 people
- Sponsor
- Stemline Therapeutics, Inc.
Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), Acute Myeloid Leukemia (AML)
Tagraxofusp in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm or Acute Myeloid Leukemia
This is a 4-stage, non-randomized, open-label, dose escalation and expansion, multicenter study. A cycle of therapy is 21 days. Stage 1 was a dose-escalation stage.
- Trial name
- NCT02113982
- Testing
- Tagraxofusp
- Where
- 9 sites in United States
- Volunteers
- 138 people
- Sponsor
- Stemline Therapeutics, Inc.
Multiple Myeloma
SL-401 in Combination With Pomalidomide and Dexamethasone in Relapsed or Relapsed and Refractory Multiple Myeloma
A Phase 1/2, Open Label Study of SL-401 in Combination with Pomalidomide and Dexamethasone In Relapsed and Refractory Multiple Myeloma
- Trial name
- NCT02661022
- Testing
- SL-401 7 µg/kg/day, SL-401 9 µg/kg/day
- Where
- 3 sites in United States
- Volunteers
- 9 people
- Sponsor
- Stemline Therapeutics, Inc.